The New Drug Approval Process: NDA Submission and Review
- Recognize the content and organization of a full New Drug Application
- Become familiar with:
- User fees and goals under the Prescription Drug User Fee Act (PDUFA)
- Expedited review programs
- Best practices when interacting with FDA
Lauren Farruggia, Associate, Goodwin Procter LLP
This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2022.
- +$100 for nonmembers
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